Mojo 2 Full Face Vented Mask Recalled: Magnet Contraindications Updated
SleepNet Corporation is recalling 2,787 units of the Mojo 2 Full Face Vented Mask due to updates needed for contraindications and warning language regarding magnets in the device. Worldwide distribution.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as FDA Class I by the agency. Per the severity rubric, FDA Class I recalls must receive a minimum score of 4 (Severe), as they indicate a potentially serious hazard requiring immediate corrective action.
Plain-English summary
SleepNet Corporation is recalling 2,787 units of the Mojo 2 Full Face Vented Mask across all sizes due to the presence of magnets in the device. The U.S. Food and Drug Administration classified this as a Class I recall.
The recall involves updates to the contraindications and warning language on the product to address hazards associated with the magnets contained in the masks. The manufacturer determined that the existing contraindications and warnings required revision.
The affected masks have been distributed worldwide, including throughout the United States and to more than 40 countries including Austria, Brazil, France, Germany, Japan, and others.
Users of the Mojo 2 Full Face Vented Mask should review the updated contraindication and warning information provided by SleepNet Corporation. Consumers with concerns about their device should contact the manufacturer or consult their healthcare provider.
The recalled product
- Product
- Mojo 2 Full Face Vented Mask, All Sizes
- Manufacturer
- SleepNet Corporation
- Category
- Medical Device — CPAP Equipment
- Hazard
- magnetic-interference
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All UDI-DI
- All Lot Numbers.
Distribution
Distributed nationwide across the United States.
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